Head of Medical & Scientific Affairs

This individual will provide strategic leadership as well as manage and develop medical team members in the Medical/Scientific Liaisons, Scientific Advisors, Pharmacovigilance, Medical Communications, Evidence Generation, and Regulatory departments in Canada. This role will have a key governance role with a focus on ensuring compliance with relevant laws and regulations, as well as internal standards and SOPs. This individual will contribute to the achievement of business success by putting the patient’s needs and safety into primary focus. This leader will also represent local medical functions in a professional and competent manner towards internal and external stakeholders, ensuring alignment across all departments. This role will represent Medical Affairs on the Canadian Leadership as well as within Takeda at the global and regional levels.  It is expected the incumbent will maintain an enterprise mindset while driving medical innovation and elevating the value of Medical Affairs within the organization.

KEY JOB ACCOUNTABILITIES 

Leadership 

• Leverage strong leadership culture to develop and retainhighly qualified employees withinthe company and establishan environment of medical excellenceand patient focus to achieve ambitious objectives.

• Lead local processes to hire experienced medical employees. 

• Support and oversight of on-boarding, medical and scientific training and knowledge transfer together with regional and global medical affairs for medicalemployeesto ensure adherence to internal standards as well as ongoing skills training on negotiations, presentations and networking. 

• Planning and control of medical department plans, resourcing, and budget. 

• Member of the company’s local Crisis Management Team. 

• Member of the company’s localCanadian Leadership Team, representing Medical & Scientific Affairs and contributing to the overall strategy and leadership of the Canadian entity

• Role model for Takeda’s Leadership Behaviours and Values. 

The following accountabilities may be delegated or shared with this position having the direct accountability or oversight and governance accountabilities.

Clinical Development  

• Final responsible person for the development of clinical research plan according to gap analysis and in alignment with global and local functions (i.e. Market access). 

• Responsible for scientific integrity, GCP adherence, (global) strategic alignment, safety, design, high quality and timely conduct of local clinical studies. 

• Oversee the evaluation and support of local investigator initiated sponsored research proposals to ensure global strategic alignment and execution in line with the company’s standards. 

• Facilitate and support local GCP audits and inspections and oversee completion of GCP related commitments or CAPAs according to the agreed timelines. 

Medical/Scientific Affairs 

• Ensure local medical activities are scientifically sound, within guidelines/directives and the LOC/Regional/Global compliance standards/SOPs, within budget and of appropriate quality and aligned with business strategy and customer and patient needs. 

• Oversee development of local strategic medical plans in line with product Life Cycle Management plans and execution (including the production of local publications, planning and conduct of local advisory board meetings, etc.).

• Liaise with other department heads to ensure common understanding of customer needs and alignment on applied strategy. 

• Establish and maintain (in alignment with regional and global medical affairs) strong relationships with Key Opinion Leaders. 

• Establish network including medical, clinical and academic community, authorities, pharma industry, payers and other relevant stakeholders. 

• Establish and develop Medical Liaison Managers in the country including territory alignment, targeting and segmentation. 

• Provide medical contribution to tender business offers and negotiations. 

• Anticipate or identify changes in the marketplace that may provide scientific, medical, regulatory and/or commercial opportunities for the company. 

• Provide medical contribution to market access, reimbursement applications and negotiations. 

• Support local business development/in-licensing activities with scientific evaluations. 

• Act as medical and scientific expert for the company in external engagements and communications.

• Act as a company representative in front of competent authorities for subjects under his/her responsibility. 

• Responsible for the timely and competent handling of all scientific/medical, pharmacovigilance, and regulatory strategies, aspects related to all marketed and developing company products in accordance withappropriate international and regional guidelines/directives, local law and company standards/SOPs. 

• Develop and oversee execution of medical training of medical team members in all disciplines across the Medical & Scientific Affairs function. 

• Guarantee scientific accuracy and adherence to ethical and industry standards regarding medical information, medicalemployees and sales force training, promotion of products marketed by the company, in accordance withall regulatory bodies and the company’s standards / SOPs. 

• Act as communication link between local departments and regional/global medical functions. 

• Establish a KPIs system for MSLs and operationalize in CRM. 

• Develop Health Care Professional mapping and segmentation principles as basis of MSL territory alignment in coordination with cross-functional colleagues where applicable; set standards for local/regional Health Care Professional mapping by MSLs. 

Regulatory Affairs 

• Nominate a local regulatory affairs representative.

• Oversee label creation, review and approval processes for the affiliate. 

• Support (global products) or oversee (local products) regulatory submissions to local regulatory authority. 

• Oversee communication with local regulatory authority. 

• Guarantee accuracy and adherence to local regulatory authorities’ legislation, guidelines and other relevant documents and proactively inform management on relevant changes. 

Medical Information 

• Work with Global Medical Information to appropriately respond to unsolicited medical inquiries.

Quality Assurance – local oversight of:

• Support the implementation of global standards and Standard Operating Procedures that are aligned with local requirements.

• Oversee development and maintenance of GxP related controlled documents in the local quality management system.

Pharmacovigilance – local oversight of:

• Ensure robust, consistent and compliant LOC pharmacovigilance alignment with Global PV.

• Ensure basic pharmacovigilance training of all company employees in Canada and of all external service providers involved in activities, where potential AEs are likely to be reported. 

• Nominate a local drug safety officer and deputy. 

• Oversee all pharmacovigilance related responsibilities and activities undertaken in the company. 

• Facilitate and support local pharmacovigilance audits and inspections and oversee completion of pharmacovigilance related commitments or CAPAs according to the agreed timelines. 

REQUIRED EDUCATION, SKILLS AND EXPERIENCE

Education: 

• M.D.required, further qualifications (e.g.MBA) advantageous. 

Professional Work Experience: 

• 12+ years pharmaceutical or biotech industry experience with a focus in medical/scientific affairs function (medical information, grant processing, field MSL team, KOL management, and scientific communications). 

• 5+ years direct management experience leading multi-functional teams. 

• Knowledge of or willingness to gain a comprehensive knowledge of the Canadian health and regulatory environment.

• Extensive regulatory and compliance experience leading a medical/scientific affairs organization. 

• Ability to work in intense, fast paced, matrixed, multi-faceted work environment. 

• Excellent interpersonal skills with demonstratedtrack record and ability to drive results as an effective team member and project leader. 

• Must demonstrate leadership and bring a positive approach to all challenges, strong ethics, and responsibility. 

• Champion for and experience in utilizing digital tools and supporting innovation 

Therapeutic Area Experience: 

• 5+ years in specialty pharmaceutical and/or oncology areas, with proven record of contribution to medical/scientific affairs industry. 

Communications: 

• Ability to effectively communicate fluently in English with employees, colleagues, and affiliates (written and oral). 

• Fluency in oral and written French is stronglypreferred. 

IN-OFFICE ATTENDANCE AND TRAVEL REQUIREMENTS

• Hybrid role with an expectation of at minimum 2 days per week in office and more ifrequired according to the business priorities/cycle

• Travel, both domestic and international, is required for this role; up to 40% of the time.